TERMINATED

A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a parallel, Phase 2, 3-arm study to evaluate the efficacy, safety, PK, and biological effects of SAR444656 compared with placebo in adult participants with moderate to severe HS aged ≥18 to 70 years. Study details include: * Screening period: up to 4 weeks (30 days) * Treatment duration: up to 16 weeks * Follow-up period: up to 4 weeks * Total study duration: up to 24 weeks * Number of visits: 14

Official Title

A Parallel-group Treatment, Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR444656 in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Quick Facts

Study Start:2023-09-29

Study Completion:2025-11-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06028230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline. * Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III. * Participant must have had an inadequate response after at least one-month of oral antibiotic treatment for HS, as assessed by the Investigator. * Participant must have a total AN count of ≥5 at the baseline visit. * Participant must have a draining tunnel count of ≤20 at the baseline visit. * Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol. * Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.	* Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS. * Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline. * Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. * Participant with history of solid organ transplant. * Participant with history of splenectomy. * Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed. * Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS * Participant with family history of sudden death or long QT syndrome. * Participant with history of congenital or drug-induced long QT syndrome. * Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease. * Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening. * Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology. * Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication. * Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit. * Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions: * Discontinued due to treatment related toxicity and/or * Discontinuation is not related to lack or loss of therapeutic response.

Inclusion Criteria

Exclusion Criteria

* Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline.
* Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III.
* Participant must have had an inadequate response after at least one-month of oral antibiotic treatment for HS, as assessed by the Investigator.
* Participant must have a total AN count of ≥5 at the baseline visit.
* Participant must have a draining tunnel count of ≤20 at the baseline visit.
* Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol.
* Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

* Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS.
* Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline.
* Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Participant with history of solid organ transplant.
* Participant with history of splenectomy.
* Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for ≥5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed.
* Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS
* Participant with family history of sudden death or long QT syndrome.
* Participant with history of congenital or drug-induced long QT syndrome.
* Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease.
* Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening.
* Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology.
* Participant with uncontrolled hypertension defined as consistent systolic blood pressure ≥150 mmHg or consistent diastolic blood pressure ≥90 mmHg despite antihypertensive medication.
* Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit.
* Prior or active treatment with any systemic biologic (anti-TNF) therapy, anti-IL17 therapy, anti-IL1/anti-IL1 receptor therapy except for up to 20% of the total study population. Furthermore, this 20% of biologic-experienced participants must fulfilled one or more of the following conditions:
* Discontinued due to treatment related toxicity and/or
* Discontinuation is not related to lack or loss of therapeutic response.

Contacts and Locations

Study Locations (Sites)

Clear Dermatology & Aesthetics Center- Site Number : 8400006

Scottsdale, Arizona, 85255

United States

Cosmetic Dermatology of Orange County- Site Number : 8400024

Anaheim, California, 92807

United States

First OC Dermatology - Fountain Valley- Site Number : 8400007

Fountain Valley, California, 92708-3701

United States

Paradigm Clinical Research - San Diego - ClinEdge - PPDS- Site Number : 8400021

San Diego, California, 92108

United States

Clinical Trials Management Services - Thousand Oaks- Site Number : 8400028

Thousand Oaks, California, 91360

United States

Advanced Dermatology and Cosmetic Care- Site Number : 8400025

Valencia, California, 91355

United States

Encore Medical Research of Boynton Beach- Site Number : 8400002

Boynton Beach, Florida, 33436

United States

Moore Clinical Research - Brandon- Site Number : 8400001

Brandon, Florida, 33511

United States

Encore Medical Research - 6600 Taft St- Site Number : 8400005

Hollywood, Florida, 33024

United States

Sullivan Dermatology- Site Number : 8400003

Miami, Florida, 33162

United States

ARA Professionals- Site Number : 8400023

Miami, Florida, 33176-1032

United States

Encore Medical Research - Weston- Site Number : 8400010

Weston, Florida, 33331

United States

Dermatology Specialists Research (DS Research) - Indiana- Site Number : 8400012

Clarksville, Indiana, 47129

United States

Dawes Fretzin Clinical Research- Site Number : 8400011

Indianapolis, Indiana, 46256

United States

Beth Israel Deaconess Medical Center - 110 Francis St- Site Number : 8400013

Boston, Massachusetts, 02215-5563

United States

Wayne Health - Dearborn- Site Number : 8400004

Dearborn, Michigan, 48124-4085

United States

Revive Research Institute-1575 W Big Beaver Rd- Site Number : 8400008

Troy, Michigan, 48084-3536

United States

Vial Health - DermDox Dermatology- Site Number : 8400020

Camp Hill, Pennsylvania, 17011

United States

Clinical Research Philadelphia,LLC- Site Number : 8400026

Philadelphia, Pennsylvania, 19114-1025

United States

UPMC Montefiore- Site Number : 8400009

Pittsburgh, Pennsylvania, 15213

United States

Dermatology Specialists of Spokane- Site Number : 8400015

Spokane, Washington, 99202-1332

United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29

Study Completion Date2025-11-12

Study Record Updates

Study Start Date2023-09-29

Study Completion Date2025-11-12

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa